Catheterization Tray & Kit
FDA 510(k) K780259 · Argon Medical Corp.
510(k) numberK780259
Submission
- Device name
- Catheterization Tray & Kit
- Applicant
- Argon Medical Corp.
Mchenry, IL, US - Received
- February 15, 1978
- Decision date
- April 18, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K022306 | Aart Silicone TubingKGZ · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 10/10/2002SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | Byron Medical | 02/10/1998SE |
| K973183 | Wound Drainage HolderKGZ · Traditional | R & D Medical Products, Inc. | 01/23/1998SE |
| K955433 | Duralastic Silicone TubingKGZ · Traditional | Allied Biomedical Corp. | 01/26/1996SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | Navarre Biomedical , Ltd. | 07/08/1994SE |
| K896087 | Palestrant Irrigation and Drainage SetKGZ · Traditional | North American Instrument Corp. | 11/03/1989SE |
| K895041 | Optical Catheter(Tm) Introducer SetsKGZ · Traditional | Medical Dynamics, Inc. | 10/16/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
| K873009 | Concept Switching StickKGZ · Traditional | Concept, Inc. | 08/17/1987SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
More from Health Care Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130730 | V-Stick Vascular Access SetDYB · Special | 11/22/2013SE |
| K904994 | Closed System Flush SetDXT · Traditional | 01/15/1991SE |
| K895511 | Catheter Balloon Dilator Pressure GaugeMAV · Traditional | 02/28/1990SE |
| K894157 | ObturatorDYB · Traditional | 09/28/1989SE |
| K891022 | Introducer for Ptca Guiding CathetersDYB · Traditional | 05/19/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | 01/11/1989SE |
| K882221 | Over the Needle Catheter, Arterial Catheter NeedleDYB · Traditional | 08/12/1988SE |
| K871297 | Kadir Hi-Torque Guide WireKOD · Traditional | 04/10/1987SE |
| K853312 | Argon Cut Biopsy Needles, Various SizesDWO · Traditional | 09/12/1985SE |
| K852880 | Peel-Away Sheath(A Component of Argon Introd Set)DYB · Traditional | 08/29/1985SE |
Questions and answers
When was Catheterization Tray & Kit cleared by the FDA?
Catheterization Tray & Kit (K780259) received a 510(k) decision of Substantially Equivalent on April 18, 1978, 62 days after the submission was received.
What is the product code of K780259?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.